FDA.reportPublic FDA data

DISPOSABLE CYTOLOGY BRUSH

Primary DI
04953170466007
Brand
DISPOSABLE CYTOLOGY BRUSH
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
BC-202D-3010
Catalog number
N6194641
Published
2025-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251279000Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation2025-06-12BTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170466004PackageGS110Not in Commercial Distribution
04953170466007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046600414953170466004
04953170466007049531704660074953170466007

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466724DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466731DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466748DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466755DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170465987DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170465994DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466014DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466021DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465984DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465991DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466004DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466011DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466028DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170409011Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-15
04953170408984Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-05
04953170406171Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
14953170406178Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
10884521809574superDimensionCovidien LPBTG2020-10-16
10884521809581superDimensionCovidien LPBTG2020-10-16
20884521809571superDimensionCovidien LPBTG2020-10-16
20884521809588superDimensionCovidien LPBTG2020-10-16
04953170401961Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
14953170401968Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
08714729746232CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746249CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746300CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746331CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
10653405052340CONMEDConmed CorporationBTG2016-09-24
10884521200548superDimensionCovidien LPBTG2016-09-24
10884521200555superDimensionCovidien LPBTG2016-09-24